Bioequivalence Study of Rifampicin 150 mg/Isoniazid 75 mg Film-Coated Tablets Manufactured by PT Kimia Farma Tbk in Comparison with Rifinah® 300 mg/150 mg Film-Coated Tablets Manufactured by Sanofi S.r.l, Anagni, Italy for Genzyme Europe B.V., Amsterdam, Netherlands

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-3P73YX80
Tanggal Input Registry : 03-02-2025

20-05-2024
Cmax and AUCt
 
Bioequivalence Study of Rifampicin 150 mg/Isoniazid 75 mg Film-Coated Tablets Manufactured by PT Kimia Farma Tbk in Comparison with Rifinah® 300 mg/150 mg Film-Coated Tablets Manufactured by Sanofi S.r.l, Anagni, Italy for Genzyme Europe B.V., Amsterdam, Netherlands
Bioequivalence Study of Rifampicin 150 mg/Isoniazid 75 mg Film-Coated Tablets Manufactured by PT Kimia Farma Tbk in Comparison with Rifinah® 300 mg/150 mg Film-Coated Tablets Manufactured by Sanofi S.r.l, Anagni, Italy for Genzyme Europe B.V., Amsterdam, Netherlands
Interventional
Rifampicin 150 mg/Isoniazid 75 mg film-coated tablets
26
 

Inclusion Criteria:

Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures, Subjects healthy male and female, Subjects’ age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following range, Systolic blood pressure: 90 – 129 mmHg, Diastolic blood pressure: 60 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, Subjects had received the complete primary SARS CoV-2 vaccine, Subjects had negative result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine

Exclusion Criteria:

those who were pregnant and/or nursing condition, those with a history of hypersensitivity or contraindication to rifampicin or isoniazid, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significant allergic disease, or allergic reaction, those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, those who had history or presence of jaundice, those who had history or presence of diabetes mellitus, those who had history of previous treatment for tuberculosis (TB) or was suspected from TB, those who recently use of oral (2 weeks) or IV (2 – 3 months) antibiotics to assure normal bowel flora at study start, those who had history or presence of hematology disorder, coagulation disorder, tendency of bruise easily, or clinically significant hematology abnormalities, those who disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout study period, those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day, those who had participated in any clinical study within the past 90 days prior to the study, those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study, those who smoker, those with history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days, those who with history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days, those who positive result for HIV, HbsAg, and HCV tests (to be kept confidential), those who had history of drug or alcohol abuse within 12 months prior to screening for this study, those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-158/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
789/STD/PML/2023
Nabila Mudin S